Skip to content

DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set

by Macromedics BV

510(k) K250429

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250429↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250429 Date19 Mar 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IYE
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DSPS-Prominent Baseplate and Cradle systems are orthopaedic positioning aids designed to stabilize and support limbs during surgical procedures. These devices are intended for use with linear accelerators in radiation therapy, ensuring precise alignment and immobilization of the patient’s anatomy for targeted treatment. The baseplate and cradles are engineered to accommodate various anatomical regions, while the mask sets provide additional immobilization for the head and torso, enhancing treatment accuracy and safety.

These devices are supplied as reusable medical equipment, compatible with MRI environments as indicated by the MR designation. They are intended for use in radiology settings, adhering to regulatory standards including FDA 510K clearance and MDR compliance. Each model is uniquely referenced for identification, with sizes and configurations tailored for specific anatomical applications. Proper sterilization and maintenance protocols must be followed to ensure device integrity and patient safety.

Other devices from Macromedics BV

See all devices from Macromedics BV →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these devices designed for single-use or can they be reused after proper cleaning and sterilization?

    The DSPS-Prominent® baseplates, cradles, and mask sets are explicitly labeled as reusable medical equipment. Since they are intended for use in radiology settings, including MRI-compatible models, they must undergo proper sterilization and maintenance protocols to ensure patient safety and device integrity before reuse.

  • What types of anatomical regions do the DSPS-Prominent® Cradle systems accommodate, and how are they differentiated?

    The DSPS-Prominent® Cradle systems (I–VII) are designed to stabilize and support various anatomical regions during surgical procedures. Each cradle model (e.g., Cradle-I, Cradle-II) is uniquely referenced and tailored for specific applications, though the exact anatomical focus isn’t detailed beyond their role in immobilization for radiation therapy alignment.

  • How do I determine which mask set is best suited for my patient’s needs, and are they compatible with the baseplate and cradles?

    The mask sets (e.g., DSPS®-PROSCVR, DSPS®-PROSHVRL) are provided in pre-packaged sets of five and are intended to immobilize the head and torso for precise alignment during radiation therapy. While the data doesn’t specify direct compatibility requirements, the mask sets are designed to complement the baseplate and cradle systems by enhancing immobilization—confirming exact fit may require consultation with the manufacturer or clinical assessment.

  • What regulatory pathways have these devices undergone, and how does that affect their use in MRI environments?

    The DSPS-Prominent® devices have received FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards. The MR designation on the baseplate (113820) explicitly indicates compatibility with MRI environments, ensuring they can be safely used in radiology settings without interference. This regulatory route confirms their adherence to safety and performance standards for both radiation therapy and MRI applications.